A study that showed AstraZeneca's cholesterol fighter Crestor slashed deaths, heart attacks, strokes and artery-clearing procedures in apparently healthy patients has made a dramatic impression on some doctors who now expect an adjustment to preventive care guidelines.
"It's a landmark study. I think it's going to very much change the concept of primary prevention," Dr Christie Ballantyne of Methodist DeBakey Heart and Vascular Center in Houston said in an interview.
"A lot of us have thought for a long time that it makes sense to start preventive treatment early. Why wait until someone gets heart disease?," said Ballantyne, who has been involved in cholesterol and heart care for some 20 years.
"This is clearly going to influence practice and future guidelines."
In the AstraZeneca-funded Jupiter study, which was unveiled at the American Heart Association meeting on Sunday, middle-aged subjects with low cholesterol but elevated levels of a protein that has been linked to heart disease who took Crestor had a 45% reduction in serious heart problems and 20% reduction in death from all causes compared to those who received a placebo.
"These are extremely impressive clinical event reduction results. It reduced mortality by 20% in only 1.9 years and reduced all of the other events by between 40% and 50%," said Dr Carl "Chip" Lavie, director of cardiac rehabilitation and prevention at the Ochsner Heart and Vascular Institute in New Orleans.
For every 25 patients treated with Crestor in the 17,802-patient study, one serious heart event was avoided and one death was prevented for every 180 patients. All were subjects who would not be prescribed statins under current cholesterol guidelines.
The study may not only widen use of the popular cholesterol medicines known as statins to patients previously considered at low risk for heart disease, but puts C-reactive protein – an indication of arterial inflammation – in the spotlight.
An editorial on the Jupiter study in the New England Journal of Medicine did not recommend routine measurement of C-reactive protein, saying that current guidelines calling for testing patients deemed to have an intermediate heart disease risk "remains reasonable."
"I believe that this study will expand the use of statins even further in primary prevention," Lavie said. "Although the nicely written editorial suggests against this, I also believe that it will expand the use for CRP testing in clinical practice."
Ballantyne is all for it.
"I order CRP testing frequently," he said. "In primary prevention when trying to decide someone's risk it's an inexpensive test."
"Cardiovascular disease is the number one cause of pain, suffering and death in the US. We can change this, so I'm in favour of a more aggressive approach."
Ballantyne found particular significance in data that showed the same life-saving benefits in women, an undertreated portion of the population, as men.
"We can stop this ridiculous debate about treating women. The answer is yes, women benefit just like men and you don't have to wait until someone has heart disease to do something," he said.
In a crowded field that now includes several cheap, generic options, the Jupiter results should give AstraZeneca's sales force powerful new ammunition as it tries to further expand use of the drug that had sales of $922m in the third quarter and about a 9% market share.
"This trial is going to increase Crestor use," predicted Lavie, who believes the drug could steal market share from Pfizer's Lipitor, the world's most widely prescribed medicine.
"Lipitor has a ton of (positive) data, but this trial is as important, or more important, as any statin paper ever done," he said.
Lavie believes Jupiter will have some immediate impact on medical practice "but it's got to get into the (treatment) guidelines to really impact primary care."
The Journal editorial questioned the high cost of Crestor, known chemically as rosuvastatin, compared to cheap generics. But researchers pointed out that if the more powerful treatments reduce hospitalisations and surgical procedures they may actually save money over the long haul.
"This is very good news for doctors and patients on how to prevent heart attacks and strokes," Ballantyne said.
By Bill Berkrot and Ransdell Pierson, Reuters.
